Systems for treating skin laxity

ABSTRACT

A system and method for ultrasound treatment of skin laxity are provided. Systems and methods can include ultrasound imaging of the region of interest for localization of the treatment area, delivering ultrasound energy at a depth and pattern to achieve the desired therapeutic effects, and/or monitoring the treatment area to assess the results and/or provide feedback. In an embodiment, a treatment system and method can be configured for producing arrays of sub-millimeter and larger zones of thermal ablation to treat the epidermal, superficial dermal, mid-dermal and deep dermal components of tissue.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/692,114, issued as U.S. Pat. No. 9,427,600, which is a continuationof U.S. patent application Ser. No. 14/169,709, issued as U.S. Pat. No.9,039,619, which is a continuation of U.S. patent application Ser. No.13/230,498, issued as U.S. Pat. No. 8,641,622, which is a continuationof U.S. patent application Ser. No. 11/163,150, issued as U.S. Pat. No.8,066,641, which claims the benefit of priority to U.S. ProvisionalApplication No. 60/617,295, each of which is incorporated in itsentirety by reference herein. Any and all applications for which aforeign or domestic priority claim is identified in the Application DataSheet as filed with the present application are hereby incorporated byreference under 37 CFR 1.57.

BACKGROUND

The present invention relates to ultrasound therapy and imaging systems,and in particular to a method and system for treating photoaged tissue.

Photoaging of human skin is a complex response due to inflammation,oxidative injury, cellular and extracellular changes induced by decadesof sunlight exposure. UV wavelengths are thought to be mainlyresponsible. Both of the primary skin layers, epidermis and dermis, areaffected. Epidermal photoaging includes pigmentary lesions calledephilides (freckles) and solar lentigines (larger pigmented spots), plusprecancerous clonal lesions of keratinocytes called actinic keratoses.Thermal destruction of part or all of the epidermis, the outermostcellular layer of skin about 0.1 mm thick, is an effective treatment forepidermal photoaging. For example, lasers that vaporize epidermis arehighly effective in a treatment called laser resurfacing. However laserresurfacing creates a significant skin wound with risk of infection, andprolonged healing. Dermal changes of photoaging include solar elastosis(an accumulation of abnormally-formed elastin fibers in the upperreticular layer of the dermis), laxity, loss of elasticity, fine andcoarse wrinkles. Laser resurfacing to a depth below the dermoepidermaljunction can be highly effective for improving dermal photoaging,through a process of stimulated wound healing. Deep chemical peels,dermabrasion and other methods of destruction of epidermis and/or dermisare also effective, and also produce a significant open skin wound withrisk of infection and delayed healing.

Patterns of stimulated thermal damage to epidermis and/or dermis arealso effective for treatment of photoaging. Recently, “fractionalphotothermolysis” using mid-infrared lasers to produce a microscopicarray of thermal injury zones that include both epidermis and dermis wasreported to be effective and well-tolerated for treatment of photoaging(D. Manstein et al. “Fractional Photothermolysis: a new concept forcutaneous remodeling using microscopic patterns of thermal injury.”Lasers Surg Med 34:426-438, 2004). A primary advantage of fractionalphotothermolysis is that each zone of thermal injury is smaller than canbe easily seen with the unaided eye, and surrounded by a zone of healthytissue that initiates a rapid healing response. As described Manstein,the epidermis is stimulated to heal rapidly and without creating an openwound. The microscopic zones of thermally injured epidermis sloughharmlessly from the skin surface after several days to several weeks,leaving a rejuvenated epidermis with less photoaging changes. Repeattreatments, which are well tolerated, can be performed until a desiredresult is obtained. The microscopic zones of thermal injury withfractional photothermolysis extend well into the dermis, as well. Dermisdoes not heal as rapidly as epidermis, in general. Over weeks to monthsfollowing treatment, some of the abnormal dermis due to photoaging isremodeled, however, leading to improvement in laxity, wrinkles and skintexture.

Fractional photothermolysis (FP) is intrinsically limited to regions ofapproximately the upper 1-millimeter of skin. The basic concept ofproducing well-controlled arrays of thermal injury is therefore limitedwith fractional photothermolysis, to superficial aspects of photoaging.Aging, which also causes laxity of the skin, and photoaging involvedeeper layers of the dermis. Solar elastosis can extend throughout thedermis, to approximately 3 mm deep or more. Laxity and loss ofelasticity due to aging are bulk problems of the dermis.

A fundamental requirement for producing arrays of small thermal injuryzones using a source of radiant energy that propagates and is absorbedwithin tissue, is that the source of radiant energy be capable of beingadequately delivered to the tissue depth for which the array is desired.Near the skin surface, light can be used, as in fractionalphotothermolysis. However, light that propagates more than about 1 mmthrough skin has been multiplied scattered, and can no longer be focusedor delivered.

SUMMARY

A method and system for ultrasound treatment of photoaged tissue areprovided. An exemplary method and system are configured for first,ultrasound imaging of the region of interest for localization of thetreatment area, second, delivery of ultrasound energy at a depth andpattern to achieve the desired therapeutic effects, and third to monitorthe treatment area during and after therapy to assess the results and/orprovide feedback. The exemplary treatment method and system can beconfigured for producing arrays of sub-millimeter and larger zones ofthermal ablation to treat the epidermal, superficial dermal, mid-dermaland deep dermal components of photoaged tissue.

In accordance with an exemplary embodiment, the treatment method andsystem use focused, unfocused, and/or defocused ultrasound for treatmentof epidermal, superficial dermal, dermal, mid-dermal, and/or deep dermalcomponents of photoaged tissue by adjusting the strength, depth, and/ortype of focusing, energy levels and timing cadence. For example, focusedultrasound can be used to create precise arrays of microscopic thermaldamage much deeper into the skin or even into subcutaneous structures.Detection of changes in the reflection of ultrasound can be used forfeedback control to detect a desired effect on the tissue and used tocontrol the exposure intensity, time, and/or position.

In accordance with an exemplary embodiment, an exemplary treatmentsystem comprises an imaging/therapy probe, a control system and displaysystem. The imaging/therapy probe can comprise various probe and/ortransducer configurations. For example, the probe can be configured fora combined dual-mode imaging/therapy transducer, coupled or co-housedimaging/therapy transducers, a separate therapy probe and imaging probe,or a single therapy probe. The control system and display system canalso comprise various configurations for controlling probe and systemfunctionality, including for example a microprocessor with software anda plurality of input/output and communication devices, a system forcontrolling electronic and/or mechanical scanning and/or multiplexing oftransducers, a system for power delivery, systems for monitoring,systems for sensing the spatial position of the probe and/or temporalparameters of the transducers, and systems for handling user input andrecording treatment input and results, among others.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter of the invention is particularly pointed out in theconcluding portion of the specification. The invention, however, both asto organization and method of operation, may best be understood byreference to the following description taken in conjunction with theaccompanying drawing figures, in which like parts may be referred to bylike numerals:

FIG. 1 illustrates a block diagram of a treatment system in accordancewith an exemplary embodiment of the present invention;

FIGS. 2A-2D illustrates a schematic diagram of an ultrasound treatmentsystem including therapy, imaging and/or monitoring and treatingphotoaged tissue in accordance with various exemplary embodiments of thepresent invention;

FIGS. 3A and 3B illustrate block diagrams of an exemplary control systemin accordance with exemplary embodiments of the present invention;

FIGS. 4A and 4B illustrate block diagrams of an exemplary probe systemin accordance with exemplary embodiments of the present invention;

FIG. 5 illustrates a cross-sectional diagram of an exemplary transducerin accordance with an exemplary embodiment of the present invention;

FIGS. 6A and 6B illustrate cross-sectional diagrams of an exemplarytransducer in accordance with exemplary embodiments of the presentinvention;

FIG. 7 illustrates exemplary transducer configurations for ultrasoundtreatment in accordance with various exemplary embodiments of thepresent invention;

FIGS. 8A and 8B illustrate cross-sectional diagrams of an exemplarytransducer in accordance with another exemplary embodiment of thepresent invention;

FIG. 9 illustrates an exemplary transducer configured as atwo-dimensional, array for ultrasound treatment in accordance with anexemplary embodiment of the present invention;

FIGS. 10A-10F illustrate cross-sectional diagrams of exemplarytransducers in accordance with other exemplary embodiments of thepresent invention;

FIG. 11 illustrates a schematic diagram of an acoustic coupling andcooling system in accordance with an exemplary embodiment of the presentinvention;

FIG. 12 illustrates a block diagram of an ultrasound treatment systemcombined with additional subsystems and methods of treatment monitoringand/or treatment imaging as well as a secondary treatment subsystem inaccordance with an exemplary embodiment of the present invention; and

FIG. 13 illustrates a schematic diagram with imaging, therapy, ormonitoring being provided with one or more active or passive oralinserts in accordance with an exemplary embodiment of the presentinvention.

DETAILED DESCRIPTION

The present invention may be described herein in terms of variousfunctional components and processing steps. It should be appreciatedthat such components and steps may be realized by any number of hardwarecomponents configured to perform the specified functions. For example,the present invention may employ various medical treatment devices,visual imaging and display devices, input terminals and the like, whichmay carry out a variety of functions under the control of one or morecontrol systems or other control devices. In addition, the presentinvention may be practiced in any number of medical contexts and thatthe exemplary embodiments relating to a method and system for treatingphotoaged tissue as described herein are merely indicative of exemplaryapplications for the invention. For example, the principles, featuresand methods discussed may be applied to any medical application.Further, various aspects of the present invention may be suitablyapplied to other applications.

In accordance with various aspects of the present invention, a methodand system for treating photoaged tissue are provided. For example, inaccordance with an exemplary embodiment, with reference to FIG. 1, anexemplary treatment system 100 configured to treat a region of interest(ROI) 106 comprises a control system 102, an imaging/therapy probe withacoustic coupling 104, and a display system 108. Control system 102 anddisplay 108 can comprise various configurations for controllingfunctionality of probe 104 and system 100, including for example amicroprocessor with software and a plurality of input/output andcommunication devices, a system for controlling electronic and/ormechanical scanning and/or multiplexing of transducers, a system forpower delivery, systems for monitoring, systems for sensing the spatialposition of the probe and/or temporal parameters of the transducers,and/or systems for handling user input and recording treatment input andresults, among others. Imaging/therapy probe 104 can comprise variousprobe and/or transducer configurations. For example, probe 104 can beconfigured for a combined dual-mode imaging/therapy transducer, coupledor co-housed imaging/therapy transducers, a separate therapy probe andseparate imaging probe, or a single therapy probe. In accordance withexemplary embodiments, imaging transducers may operate at frequenciesfrom approximately 2 to 75 MHz or more, while therapy energy can bedelivered at frequencies from approximately 2 to 50 MHz, with 2 MHz to25 MHz being typical.

For the treatment of photoaged tissue, it is desirable to be able toproduce well controlled arrays of microscopic zones of thermal injurynot only near the surface of skin, but in the mid-dermis, and/or in thedeep dermis. Thermal ablation of dermis at temperatures greater thanabout 60° C., capable of producing denaturation of tissue, is alsodesirable in such arrays of thermal lesions. Shrinkage of dermis due tothermal action results from tightening of the skin.

In contrast to optical or RF approaches, ultrasound energy propagates asa wave with relatively little scattering, over depths up to manycentimeters in tissue depending on the ultrasound frequency. The focalspot size achievable with any propagating wave energy, depends onwavelength. Ultrasound wavelength is equal to the acoustic velocitydivided by the ultrasound frequency. Attenuation (absorption, mainly) ofultrasound by tissue also depends on frequency.

In accordance with an exemplary embodiment, the use of focused,unfocused, or defocused ultrasound for treatment of epidermal,superficial dermal, dermal, middermal, and deep dermal components ofphotoaged tissue through adjustment of the strength, depth, and type offocusing, energy levels and timing cadence. For example, focusedultrasound can be used to create precise arrays of microscopic thermalablation zones which have several advantages over fractionalphotothermolysis (FP). At high frequency and with superficial focusingor diffraction pattern, ultrasound ablation can mimic FP but utilize asimpler ablation device. Unlike fractional photothermolysis, ultrasoundcan produce an array of ablation zones much deeper into the skin or eveninto subcutaneous structures. Detection of changes in the reflection ofultrasound can be used for feedback control to detect a desired effecton the tissue and used to control the exposure intensity, time, and/orposition.

To further illustrate the use of ultrasound for the treatment ofphotoaged tissue, with reference to FIG. 2A, an exemplary method andsystem are configured for initially imaging a region 222 of a region ofinterest 206 and displaying that region 224 during the localization ofthe treatment area and surrounding structures. After localization,delivery of ultrasound energy 220 at a depth, distribution, timing, andenergy level to achieve the desired therapeutic effect of thermalablation to treat an epidermis layer 212, superficial dermis layer 214,mid-dermis layer 216, and/or deep dermis layer 218 can be provided.Before, during, and after therapy, i.e., before, during, and after thedelivery of ultrasound energy 220, exemplary method and system 200 cansuitably monitor the treatment area and surrounding structures to planand assess the results and/or provide feedback to control system 202and/or a system user.

While an imaging function may be configured within control system 202 tofacilitate imaging a region of interest, in accordance with anotherexemplary embodiment, an exemplary treatment system 200 may also beconfigured for therapy only or therapy and monitoring, without imagingfunctions. In such a case prior known depth of the region of interest,approximately 0 to 5 mm or less, is employed to achieve treatment zonesin photoaged skin.

Probe 204 and/or transducers within can be mechanically and/orelectronically scanned in a direction 226 to place treatment zones 260over an extended area, such as a line to generate a matrix of closelyspaced treatment spots. Treatment depth 220 can be adjusted between arange of approximately 0 to 5 mm, or otherwise until the depth of thedeep dermis. Treatment may be confined to a fixed depth or a fewdiscrete depths, or can be adjustment limited to a fine range, e.g. fromapproximately between 0 to 5 mm or the greatest depth of the deepdermis, or can be dynamically adjusted during treatment, to the treatregion of interest 206 that lies above subcutaneous fat region 250.

In accordance with another exemplary embodiment of the presentinvention, with reference to FIG. 2B, a treated zone 260 may extendthroughout regions of the dermis, and may even extend to the epidermis,262. In addition, as a treated zone increases in depth its cross sectionmay increase from small size 264 (sub millimeter) in a shallow regionnear or at the epidermis, to medium size 266 (sub millimeter tomillimeter sized) in a middle zone near or at the mid dermis, to largesize 268 (millimeter sized) in deep zones near or at the deep dermis.Furthermore a. single treated zone can have a shape expanding in crosssection with depth, and/or be composed of the fusion of several smallertreatment zones. Spacing of treatment zones can be on the order of thetreatment zone size. The ultrasound beam can be spatially and/ortemporally controlled by changing the position of the transducer, itsfrequency, treatment depth, drive amplitude, and timing via the controlsystem. For example, the ultrasound beam can be controlled as set forthin U.S. patent application Ser. No. 11/163,148, filed Oct. 6, 2005, andentitled METHOD AND SYSTEM FOR COTROLLED THERMAL INJURY OF HUMANSUPERFICIAL TISSUE, and hereby incorporated by reference.

In accordance with another exemplary embodiment of the presentinvention, with reference to FIG. 2C, an exemplary treatment method andsystem 200 may be configured to monitor the temperature profile or othertissue parameters of region of interest 206, such as attenuation orspeed of sound of the treatment region and suitably adjust the spatialand/or temporal characteristics and energy levels of the ultrasoundtherapy transducer. The results of such monitoring techniques may beindicated on display 208, such as through display of one-, two-, orthree-dimensional images of monitoring results 270, or may comprise anindicator 272, such as a success, fail and/or completed/done type ofindication, or combinations thereof. Additional treatment monitoringmethods may be based on one or more of temperature, video, profilometry,strain imaging and/or gauges or any other suitable sensing method.

In accordance with another exemplary embodiment, with reference to FIG.20, an expanded region of interest 280 can suitably include acombination of tissues, such as subcutaneous fat/adipose tissue 250. Acombination of such tissues includes at least one of epidermis 212,superficial dermis 214, mid dermis 216, or deep dermis 218, incombination with at least one of muscle tissue, adipose tissue, or othertissues useful for treatment. For example, treatment 260 of superficialdermis may be performed in combination with treatment 220 ofsubcutaneous fat 250 by suitable adjustment of the spatial and temporalparameters of transducers in probe 204.

An exemplary control system 202 and display system 208 may be configuredin various manners for controlling probe and system functionality forproviding the various exemplary treatment methods illustrated above. Forexample, with reference to FIGS. 3A and 3B, in accordance with exemplaryembodiments, an exemplary control system 300 can be configured forcoordination and control of the entire therapeutic treatment process forproducing arrays of sub-millimeter and larger zones of thermal ablationto treat the epidermal, superficial dermal, mid-dermal and deep dermalcomponents of photoaged tissue. For example, control system 300 cansuitably comprise power source components 302, sensing and monitoringcomponents 304, cooling and coupling controls 306, and/or processing andcontrol logic components 308. Control system 300 can be configured andoptimized in a variety of ways with more or less subsystems andcomponents to implement the therapeutic system for controlled thermalinjury of photoaged tissue, and the embodiments in FIGS. 3A and 3B aremerely for illustration purposes.

For example, for power sourcing components 302, control system 300 cancomprise one or more direct current (DC) power supplies 303 configuredto provide electrical energy for entire control system 300, includingpower required by a transducer electronic amplifier/driver 312. A DCcurrent sense device 305 can also be provided to confirm the level ofpower going into amplifiers/drivers 312 for safety and monitoringpurposes.

Amplifiers/drivers 312 can comprise multi-channel or single channelpower amplifiers and/or drivers. In accordance with an exemplaryembodiment for transducer array configurations, amplifiers/drivers 312can also be configured with a beamformer to facilitate array focusing.An exemplary beamformer can be electrically excited by anoscillator/digitally controlled waveform synthesizer 310 with relatedswitching logic.

The power sourcing components can also include various filteringconfigurations 314. For example, switchable harmonic filters and/ormatching may be used at the output of amplifier/driver 312 to increasethe drive efficiency and effectiveness. Power detection components 316may also be included to confirm appropriate operation and calibration.For example, electric power and other energy detection components 316may be used to monitor the amount of power going to an exemplary probesystem.

Various sensing and monitoring components 304 may also be suitablyimplemented within control system 300. For example, in accordance withan exemplary embodiment, monitoring, sensing and interface controlcomponents 324 may be configured to operate with various motiondetection systems implemented within transducer probe 204 to receive andprocess information such as acoustic or other spatial and temporalinformation from a region of interest. Sensing and monitoring componentscan also include various controls, interfacing and switches 309 and/orpower detectors 316. Such sensing and monitoring components 304 canfacilitate open-loop and/or closed-loop feedback systems withintreatment system 200.

Cooling/coupling control systems 306 may be provided to remove wasteheat from an exemplary probe 204, provide a controlled temperature atthe superficial tissue interface and deeper into tissue, and/or provideacoustic coupling from transducer probe 204 to region-of-interest 206.Such cooling/coupling control systems 306 can also be configured tooperate in both open-loop and/or closed-loop feedback arrangements withvarious coupling and feedback components.

Processing and control logic components 308 can comprise various systemprocessors and digital control logic 307, such as one or more ofmicrocontrollers, microprocessors, field-programmable gate arrays(FPGAs), computer boards, and associated components, including firmwareand control software 326, which interfaces to user controls andinterfacing circuits as well as input/output circuits and systems forcommunications, displays, interfacing, storage, documentation, and otheruseful functions. System software and firmware 326 controls allinitialization, timing, level setting, monitoring, safety monitoring,and all other system functions required to accomplish user-definedtreatment objectives. Further, various control switches 308 can also besuitably configured to control operation.

An exemplary transducer probe 204 can also be configured in variousmanners and comprise a number of reusable and/or disposable componentsand parts in various embodiments to facilitate its operation. Forexample, transducer probe 204 can be configured within any type oftransducer probe housing or arrangement for facilitating the coupling oftransducer to a tissue interface, with such housing comprising variousshapes, contours and configurations. Transducer probe 204 can compriseany type of matching, such as for example, electric matching, which maybe electrically switchable; multiplexer circuits and/or aperture/elementselection circuits; and/or probe identification devices, to certifyprobe handle, electric matching, transducer usage history andcalibration, such as one or more serial EEPROM (memories). Transducerprobe 204 may also comprise cables and connectors; motion mechanisms,motion sensors and encoders; thermal monitoring sensors; and/or usercontrol and status related switches, and indicators such as LEDs. Forexample, a motion mechanism in probe 204 may be used to controllablycreate multiple lesions, or sensing of probe motion itself may be usedto controllably create multiple lesions and/or stop creation of lesions,e.g. for safety reasons if probe 204 is suddenly jerked or is dropped.In addition, an external motion encoder arm may be used to hold theprobe during use, whereby the spatial position and attitude of probe 104is sent to the control system to help controllably create lesions.Furthermore, other sensing functionality such as profilometers or otherimaging modalities may be integrated into the probe in accordance withvarious exemplary embodiments.

With reference to FIGS. 4A and 4B, in accordance with an exemplaryembodiment, a transducer probe 400 can comprise a control interface 402,a transducer 404, coupling components 406, and monitoring/sensingcomponents 408, and/or motion mechanism 410. However, transducer probe400 can be configured and optimized in a variety of ways with more orless parts and components to provide ultrasound energy for controlledthermal injury of photoaged tissue, and the embodiments in FIGS. 4A and4B are merely for illustration purposes.

Control interface 402 is configured for interfacing with control system300 to facilitate control of transducer probe 400. Control interfacecomponents 402 can comprise multiplexer/aperture select 424, switchableelectric matching networks 426, serial EEPROMs and/or other processingcomponents and matching and probe usage information 430 and interfaceconnectors 432.

Coupling components 406 can comprise various devices to facilitatecoupling of transducer probe 400 to a region of interest. For example,coupling components 406 can comprise cooling and acoustic couplingsystem 420 configured for acoustic coupling of ultrasound energy andsignals. Acoustic cooling/coupling system 420 with possible connectionssuch as manifolds may be utilized to couple sound into theregion-of-interest, control temperature at the interface and deeper intotissue, provide liquid-filled lens focusing, and/or to remove transducerwaste heat. Coupling system 420 may facilitate such coupling through useof various coupling mediums, including air and other gases, water andother fluids, gels, solids, and/or any combination thereof, or any othermedium that allows for signals to be transmitted between transduceractive elements 412 and a region of interest. In addition to providing acoupling function, in accordance with an exemplary embodiment, couplingsystem 420 can also be configured for providing temperature controlduring the treatment application. For example, coupling system 420 canbe configured for controlled cooling of an interface surface or deeperregion between transducer probe 400 and a region of interest and beyondby suitably controlling the temperature of the coupling medium. Thesuitable temperature for such coupling medium can be achieved in variousmanners, and utilize various feedback systems, such as thermocouples,thermistors or any other device or system configured for temperaturemeasurement of a coupling medium. Such controlled cooling can beconfigured to further facilitate spatial and/or thermal energy deliverycontrol of transducer probe 400.

In accordance with an exemplary embodiment, with additional reference toFIG. 11, acoustic coupling and cooling 1140 can be provided toacoustically couple energy and imaging signals from transducer probe1104 to and from the region of interest 1102, to provide thermal controlat the probe to region-of-interest interface 1110 and deeper intotissue, and to remove potential waste heat from the transducer probe atregion 1144. Temperature monitoring can be provided at the couplinginterface via a thermal sensor 1146 to provide a mechanism oftemperature measurement 1148 and control via control system 1106 and athermal control system 1142. Thermal control may consist of passivecooling such as via heat sinks or natural conduction and convection orvia active cooling such as with peltier thermoelectric coolers,refrigerants, or fluid-based systems comprised of pump, fluid reservoir,bubble detection, flow sensor, flow channels/tubing 1144 and thermalcontrol 1142.

With continued reference to FIG. 4, monitoring and sensing components408 can comprise various motion and/or position sensors 416, temperaturemonitoring sensors 418, user control and feedback switches 414 and otherlike components for facilitating control by control system 300, e.g., tofacilitate spatial and/or temporal control through open-loop andclosed-loop feedback arrangements that monitor various spatial andtemporal characteristics.

Motion mechanism 410 can comprise manual operation, mechanicalarrangements, or some combination thereof. For example, a motionmechanism 422 can be suitably controlled by control system 300, such asthrough the use of accelerometers, encoders or otherposition/orientation devices 416 to determine and enable movement andpositions of transducer probe 400. Linear, rotational or variablemovement can be facilitated, e.g., those depending on the treatmentapplication and tissue contour surface.

Transducer 404 can comprise one or more transducers configured fortreating of SMAS layers and targeted regions. Transducer 404 can alsocomprise one or more transduction elements and/or lenses 412. Thetransduction elements can comprise a piezoelectrically active material,such as lead zirconante titanate (PZT), or any other piezoelectricallyactive material, such as a piezoelectric ceramic, crystal, plastic,and/or composite materials, as well as lithium niobate, lead titanate,barium titanate, and/or lead metaniobate. In addition to, or instead of,a piezoelectrically active material, transducer 404 can comprise anyother materials configured for generating radiation and/or acousticalenergy. Transducer 404 can also comprise one or more matching layersconfigured along with the transduction element such as coupled to thepiezoelectrically active material. Acoustic matching layers and/ordamping may be employed as necessary to achieve the desiredelectroacoustic response.

In accordance with an exemplary embodiment, the thickness of thetransduction element of transducer 404 can be configured to be uniform.That is, a transduction element 412 can be configured to have athickness that is substantially the same throughout. In accordance withanother exemplary embodiment, the thickness of a transduction element412 can also be configured to be variable. For example, transductionelement(s) 412 of transducer 404 can be configured to have a firstthickness selected to provide a center operating frequency ofapproximately 2 kHz to 75 MHz, such as for imaging applications.Transduction element 412 can also be configured with a second thicknessselected to provide a center operating frequency of approximately 2 to50 MHz, and typically between 2 MHz and 25 MHz for therapy application.Transducer 404 can be configured as a single broadband transducerexcited with at least two or more frequencies to provide an adequateoutput for generating a desired response. Transducer 404 can also beconfigured as two or more individual transducers, wherein eachtransducer comprises one or more transduction element. The thickness ofthe transduction elements can be configured to provide center-operatingfrequencies in a desired treatment range.

Transducer 404 may be composed of one or more individual transducers inany combination of focused, planar, or unfocused single-element,multi-element, or array transducers, including 1-D, 2-D, and annulararrays; linear, curvilinear, sector, or spherical arrays; spherically,cylindrically, and/or electronically focused, defocused, and/or lensedsources. For example, with reference to an exemplary embodiment depictedin FIG. 5, transducer 500 can be configured as an acoustic array 502 tofacilitate phase focusing. That is, transducer 500 can be configured asan array of electronic apertures that may be operated by a variety ofphases via variable electronic time delays. By the term “operated,” theelectronic apertures of transducer 500 may be manipulated, driven, used,and/or configured to produce and/or deliver an energy beam correspondingto the phase variation caused by the electronic time delay. For example,these phase variations can be used to deliver defocused beams 508,planar beams 504, and/or focused beams 506, each of which may be used incombination to achieve different physiological effects in a region ofinterest 510. Transducer 500 may additionally comprise any softwareand/or other hardware for generating, producing and/or driving a phasedaperture array with one or more electronic time delays.

Transducer 500 can also be configured to provide focused treatment toone or more regions of interest using various frequencies. In order toprovide focused treatment, transducer 500 can be configured with one ormore variable depth devices to facilitate treatment. For example,transducer 500 may be configured with variable depth devices disclosedin U.S. patent application Ser. No. 10/944,500, entitled “System andMethod for Variable Depth Ultrasound”, filed on Sep. 16, 2004, having atleast one common inventor and a common Assignee as the presentapplication, and incorporated herein by reference. In addition,transducer 500 can also be configured to treat one or more additionalROI 510 through the enabling of sub-harmonics or pulseecho imaging, asdisclosed in U.S. patent application Ser. No. 10/944,499, entitled“Method and System for Ultrasound Treatment with a Multi-directionalTransducer,” filed on Sep. 16, 2004, having at least one common inventorand a common Assignee as the present application, and also incorporatedherein by reference.

Moreover, any variety of mechanical lenses or variable focus lenses,e.g. liquid-filled lenses, may also be used to focus and/or defocus thesound field. For example, with reference to exemplary embodimentsdepicted in FIGS. 6A and 6B, transducer 600 may also be configured withan electronic focusing array 604 in combination with one or moretransduction elements 606 to facilitate increased flexibility intreating ROI 610. Array 604 may be configured in a manner similar totransducer 502. That is, array 604 can be configured as an array ofelectronic apertures that may be operated by a variety of phases viavariable electronic time delays, for example, T1, T2 . . . Tj. By theterm “operated,” the electronic apertures of array 604 may bemanipulated, driven, used, and/or configured to produce and/or deliverenergy in a manner corresponding to the phase variation caused by theelectronic time delay. For example, these phase variations can be usedto deliver defocused beams, planar beams, and/or focused beams, each ofwhich may be used in combination to achieve different physiologicaleffects in ROI 610.

Transduction elements 606 may be configured to be concave, convex,and/or planar. For example, in an exemplary embodiment depicted in FIG.6A, transduction elements 606 are configured to be concave in order toprovide focused energy for treatment of ROI 610. Additional embodimentsare disclosed in U.S. patent application Ser. No. 10/944,500, entitled“Variable Depth Transducer System and Method”, and again incorporatedherein by reference.

In another exemplary embodiment, depicted in FIG. 68, transductionelements 606 can be configured to be substantially flat in order toprovide substantially uniform energy to ROI 610. While FIGS. 6A and 68depict exemplary embodiments with transduction elements 604 configuredas concave and substantially flat, respectively, transduction elements604 can be configured to be concave, convex, and/or substantially flat.In addition, transduction elements 604 can be configured to be anycombination of concave, convex, and/or substantially flat structures.For example, a first transduction element can be configured to beconcave, while a second transduction element can be configured to besubstantially flat.

With reference to FIGS. 8A and 8B, transducer 404 can be configured assingle-element arrays, wherein a single-element 802, e.g., atransduction element of various structures and materials, can beconfigured with a plurality of masks 804, such masks comprising ceramic,metal or any other material or structure for masking or altering energydistribution from element 802, creating an array of energy distributions808. Masks 804 can be coupled directly to element 802 or separated by astandoff 806, such as any suitably solid or liquid material.

An exemplary transducer 404 can also be configured as an annular arrayto provide planar, focused and/or defocused acoustical energy. Forexample, with reference to FIGS. 10A and 10B, in accordance with anexemplary embodiment, an annular array 1000 can comprise a plurality ofrings 1012, 1014, 1016 to N. Rings 1012, 1014, 1016 to N can bemechanically and electrically isolated into a set of individualelements, and can create planar, focused, or defocused waves. Forexample, such waves can be centered on-axis, such as by methods ofadjusting corresponding transmit and/or receive delays, T1, T2, T3 . . .TN. An electronic focus can be suitably moved along various depthpositions, and can enable variable strength or beam tightness, while anelectronic defocus can have varying amounts of defocusing. In accordancewith an exemplary embodiment, a lens and/or convex or concave shapedannular array 1000 can also be provided to aid focusing or defocusingsuch that any time differential delays can be reduced. Movement ofannular array 800 in one, two or three-dimensions, or along any path,such as through use of probes and/or any conventional robotic armmechanisms, may be implemented to scan and/or treat a volume or anycorresponding space within a region of interest.

Transducer 404 can also be configured in other annular or non-arrayconfigurations for imaging/therapy functions. For example, withreference to FIGS. 10C-10F, a transducer can comprise an imaging element1012 configured with therapy element(s) 1014. Elements 1012 and 1014 cancomprise a single-transduction element, e.g., a combinedimaging/transducer element, or separate elements, can be electricallyisolated 1022 within the same transduction element or between separateimaging and therapy elements, and/or can comprise standoff 1024 or othermatching layers, or any combination thereof. For example, withparticular reference to FIG. 10F, a transducer can comprise an imagingelement 1012 having a surface 1028 configured for focusing, defocusingor planar energy distribution, with therapy elements 1014 including astepped-configuration lens configured for focusing, defocusing, orplanar energy distribution.

In accordance with various exemplary embodiments of the presentinvention, transducer 404 may be configured to provide one, two and/orthree-dimensional treatment applications for focusing acoustic energy toone or more regions of interest. For example, as discussed above,transducer 404 can be suitably diced to form a one-dimensional array,e.g., transducer 602 comprising a single array of sub-transductionelements.

In accordance with another exemplary embodiment, transducer 404 may besuitably diced in two-dimensions to form a two-dimensional array. Forexample, with reference to FIG. 9, an exemplary two-dimensional array900 can be suitably diced into a plurality of two-dimensional portions902. Two-dimensional portions 902 can be suitably configured to focus onthe treatment region at a certain depth, and thus provide respectiveslices 904, 907 of the treatment region. As a result, thetwo-dimensional array 900 can provide a two-dimensional slicing of theimage place of a treatment region, thus providing two-dimensionaltreatment.

In accordance with another exemplary embodiment, transducer 404 may besuitably configured to provide three-dimensional treatment. For example,to provide three-dimensional treatment of a region of interest, withreference again to FIG. 1, a three-dimensional system can comprise atransducer within probe 104 configured with an adaptive algorithm, suchas, for example, one utilizing three-dimensional graphic software,contained in a control system, such as control system 102. The adaptivealgorithm is suitably configured to receive two-dimensional imaging,temperature and/or treatment or other tissue parameter informationrelating to the region of interest, process the received information,and then provide corresponding three-dimensional imaging, temperatureand/or treatment information.

In accordance with an exemplary embodiment, with reference again to FIG.9, an exemplary three-dimensional system can comprise a two-dimensionalarray 900 configured with an adaptive algorithm to suitably receive 904slices from different image planes of the treatment region, process thereceived information, and then provide volumetric information 906, e.g.,three-dimensional imaging, temperature and/or treatment information.Moreover, after processing the received information with the adaptivealgorithm, the two-dimensional array 900 may suitably providetherapeutic heating to the volumetric region 906 as desired.

In accordance with other exemplary embodiments, rather than utilizing anadaptive algorithm, such as three-dimensional software, to providethree-dimensional imaging and/or temperature information, an exemplarythree-dimensional system can comprise a single transducer 404 configuredwithin a probe arrangement to operate from various rotational and/ortranslational positions relative to a target region.

To further illustrate the various structures for transducer 404, withreference to FIG. 7, ultrasound therapy transducer 700 can be configuredfor a single focus, an array of foci, a locus of foci, a line focus,and/or diffraction patterns. Transducer 700 can also comprise singleelements, multiple elements, annular arrays, one-, two-, orthree-dimensional arrays, broadband transducers, and/or combinationsthereof, with or without lenses, acoustic components, and mechanicaland/or electronic focusing. Transducers configured as sphericallyfocused single elements 702, annular arrays 704, annular arrays withdamped regions 706, line focused single elements 708, 1-0 linear arrays710, 1-0 curvilinear arrays in concave or convex form, with or withoutelevation focusing, 2-D arrays, and 3-D spatial arrangements oftransducers may be used to perform therapy and/or imaging and acousticmonitoring functions. For any transducer configuration, focusing and/ordefocusing may be in one plane or two planes via mechanical focus 720,convex lens 722, concave lens 724, compound or multiple lenses 726,planar form 728, or stepped form, such as illustrated in FIG. 10F. Anytransducer or combination of transducers may be utilized for treatment.For example, an annular transducer may be used with an outer portiondedicated to therapy and the inner disk dedicated to broadband imagingwherein such imaging transducer and therapy transducer have differentacoustic lenses and design, such as illustrated in FIG. 1 OC-1 OF.

Moreover, such transduction elements 700 may comprise apiezoelectrically active material, such as lead zirconante titanate(PZT), or any other piezoelectrically active material, such as apiezoelectric ceramic, crystal, plastic, and/or composite materials, aswell as lithium niobate, lead titanate, barium titanate, and/or leadmetaniobate. Transduction elements 700 may also comprise one or morematching layers configured along with the piezoelectrically activematerial. In addition to or instead of piezoelectrically activematerial, transduction elements 700 can comprise any other materialsconfigured for generating radiation and/or acoustical energy. A means oftransferring energy to and from the transducer to the region of interestis provided.

In accordance with another exemplary embodiment, with reference to FIG.12, an exemplary treatment system 200 can be configured with and/orcombined with various auxiliary systems to provide additional functions.For example, an exemplary treatment system 1200 for treating a region ofinterest 1202 can comprise a control system 1206, a probe 1204, and adisplay 1208. Treatment system 1200 further comprises an auxiliaryimaging modality 1272 and/or auxiliary monitoring modality 1274 may bebased upon at least one of photography and other visual optical methods,magnetic resonance imaging (MRI), computed tomography (CT), opticalcoherence tomography (OCT), electromagnetic, microwave, or radiofrequency (RF) methods, positron emission tomography (PET), infrared,ultrasound, acoustic, or any other suitable method of visualization,localization, or monitoring of epidermal, superficial dermal, mid-dermaland deep dermal components within the region-of-interest 1202, includingimaging/monitoring enhancements. Such imaging/monitoring enhancement forultrasound imaging via probe 1204 and control system 1206 could compriseM-mode, persistence, filtering, color, Doppler, and harmonic imagingamong others; furthermore an ultrasound treatment system 1270, as aprimary source of treatment, may be combined with a secondary source oftreatment 1276, including radio frequency (RF), intense pulsed light(IPL), laser, infrared laser, microwave, or any other suitable energysource.

In accordance with another exemplary embodiment, with reference to FIG.13, treatment composed of imaging, monitoring, and/or therapy to aregion of interest 1302 and/or 1308 may be aided, augmented, and/ordelivered with passive or active devices 1304 and/or 1306 within theoral and/or nasal cavity, respectively. For example, if passive oractive device 1304 and/or 1306 are second transducers or acousticreflectors acoustically coupled to the mucous membranes it is possibleto obtain through transmission, tomographic, or round-trip acousticwaves which are useful for treatment monitoring, such as in measuringacoustic speed of sound and attenuation, which are temperaturedependent; furthermore such transducers could be used to treat and/orimage. In addition an active, passive, or active/passive object 1304and/or 1306 may be used to flatten the skin, and/or may be used as animaging grid, marker, or beacon, to aid determination of position. Apassive or active device 1304 and/or 1306 may also be used to aidcooling or temperature control. Natural air in the oral cavity and/ornasal cavity may also be used as passive device 1304 and/or 1306 wherebyit may be utilized to as an acoustic reflector to aid thicknessmeasurement and monitoring function.

The present invention has been described above with reference to variousexemplary embodiments. However, those skilled in the art will recognizethat changes and modifications may be made to the exemplary embodimentswithout departing from the scope of the present invention. For example,the various operational steps, as well as the components for carryingout the operational steps, may be implemented in alternate waysdepending upon the particular application or in consideration of anynumber of cost functions associated with the operation of the system,e.g., various of the steps may be deleted, modified, or combined withother steps. These and other changes or modifications are intended to beincluded within the scope of the present invention, as set forth in thefollowing claims.

What is claimed is:
 1. An ultrasound system for treatment of skinlaxity, the system comprising: an ultrasound probe comprising a housing,wherein the housing comprises a motion mechanism and an ultrasoundtransducer, wherein the ultrasound transducer comprises a therapycomponent, wherein the therapy component consists of: a single activefocused ultrasound therapy element, wherein the ultrasound therapyelement is configured to provide a single mechanical focus, wherein thesingle mechanical focus is configured to provide ultrasound therapyenergy in a form of a single thermal focus in a tissue at a depth belowa skin surface, wherein the depth is a single, fixed depth in a range ofup to 5 mm below the skin surface to treat the tissue, wherein thetissue comprises a combination of any of the group consisting of: anepidermal tissue, a superficial dermal tissue, a mid-dermal tissue, adeep dermal tissue, a muscle tissue, and an adipose tissue, wherein thesingle thermal focus is formed without electronic focusing and without alens, wherein a portion of the ultrasound probe is configured foracoustic coupling to the skin surface; a control system connected to themotion mechanism and the ultrasound therapy element; an input deviceconnected to the control system; and a power supply connected to thecontrol system; wherein the ultrasound therapy element is configured fordelivery of energy at a temperature sufficient to tighten at least aportion of the tissue at the depth under the skin surface, wherein theultrasound therapy element is connected to the motion mechanism, whereinthe motion mechanism moves the ultrasound therapy element to form aplurality of thermal lesions at the depth for tighten at least a portionof the tissue for reducing an appearance of skin laxity.
 2. The systemof claim 1, wherein the ultrasound therapy element is configured toincrease the temperature of the tissue in the region of interest togreater than 60° C.
 3. The system of claim 1, further comprising amonitoring system, wherein the monitoring system is configured tomonitor a treatment parameter, wherein the treatment parameter measuredcomprises a temperature of the tissue below the skin surface, whereinthe housing further comprises a temperature monitoring sensor, whereinthe therapy element is a single element that delivers ultrasound energyat a frequency of between 2 MHz to 25 MHz.
 4. The system of claim 1,wherein the housing contains a temperature monitoring sensor, whereinthe control system comprises a processor, software, and a communicationdevice, wherein the ultrasound probe is connected to the control systemvia a cable, wherein the processor relays data from the temperaturemonitoring sensor via the communication device.
 5. The system of claim1, wherein the motion mechanism comprises an encoder and the ultrasoundtherapy energy is configured to deliver an energy level for causing atleast one of shrinking collagen and denaturing the tissue in the regionof interest under a wrinkle, wherein the therapy element delivers theultrasound therapy energy at a frequency of between 2 MHz to 25 MHz. 6.The system of claim 1, wherein the control system comprises a spatialcontrol and a temporal control, wherein the spatial control and thetemporal control are configured for controlling the delivery of energyat a temperature sufficient to cause denaturation of at least theportion of the tissue at the depth under the skin surface, wherein thespatial control and the temporal control are configured for controllingthe delivery of energy at a frequency of between 2 MHz to 25 MHz.
 7. Anultrasound system for treatment of skin laxity, the system comprising:an ultrasound probe configured for delivery of an ultrasound therapyenergy at a temperature sufficient to heat at least a portion of atissue at a depth under a skin surface, wherein the tissue comprises acombination of any of the group consisting of: an epidermal tissue, asuperficial dermal tissue, a mid-dermal tissue, a deep dermal tissue, amuscle tissue, and an adipose tissue; and a control system; wherein theultrasound probe comprises a housing, wherein the housing comprises anultrasound transducer, wherein the ultrasound transducer comprises atherapy component, wherein the therapy component consists of: a singleactive ultrasound therapy element, wherein the single active ultrasoundtherapy element is configured to provide a single mechanical focus,wherein the single mechanical focus is configured to provide ultrasoundtherapy energy in the form of a single thermal focus in the tissue at adepth below a skin surface, wherein the single thermal focus is formedwithout electronic focusing and without a lens, wherein the ultrasoundtherapy element is in communication with the control system, wherein theultrasound therapy element is configured for delivery of the ultrasoundtherapy energy at the temperature sufficient to heat the at least aportion of the tissue at the depth under the skin surface, wherein theultrasound probe forms a plurality of thermal lesions at the depth forreducing the appearance of skin laxity.
 8. The system of claim 7,wherein the region of interest comprises the tissue, wherein the skinsurface comprises a wrinkle, and wherein the plurality of thermallesions tightens the tissue.
 9. The system of claim 7, furthercomprising a monitoring system, wherein the monitoring system isconfigured to monitor a treatment parameter, wherein the treatmentparameter measured comprises a temperature of the tissue below the skinsurface, wherein the housing further comprises a temperature monitoringsensor, wherein the ultrasound therapy element delivers the ultrasoundtherapy energy at a frequency of between 2 MHz to 75 MHz.
 10. The systemof claim 7, wherein the ultrasound probe is connected to the controlsystem via a cable, and wherein the control system comprises: acommunication device; a processor, software, an input device, and apower supply.
 11. The system of claim 7, wherein the ultrasound therapyelement is a single element that delivers the ultrasound therapy energyat a frequency of between 2 MHz to 25 MHz, wherein the ultrasoundtherapy element is configured to increase the temperature of the tissuein the region of interest to greater than 60° C.
 12. An ultrasoundsystem for treatment of skin laxity, the system comprising: anultrasound probe comprising a housing, wherein the housing comprises anultrasound transducer, wherein the ultrasound transducer comprises atherapy component, wherein the therapy component consists of: a singleactive focused ultrasound therapy element, wherein the ultrasoundtherapy element is configured to provide a single mechanical focus,wherein the single mechanical focus is configured to provide ultrasoundtherapy energy in the form of a single thermal focus in a tissue at adepth below a skin surface, wherein the depth is up to 5 mm below theskin surface, wherein the tissue comprises a combination of any of thegroup consisting of: an epidermal tissue, a superficial dermal tissue, amid-dermal tissue, a deep dermal tissue, an adipose tissue, and a muscletissue, wherein the single thermal focus is formed without electronicfocusing and without a lens, and a control system comprising a processorand power supply; wherein the ultrasound therapy element is incommunication with the control system, wherein the ultrasound therapyelement is configured for delivery of the ultrasound therapy energy at atemperature sufficient to denature at least a portion of the tissue inthe region of interest at a depth under the skin surface, wherein theultrasound therapy element forms a plurality of thermal lesions at thedepth for tightening the tissue for reducing skin laxity.
 13. The systemof claim 12, wherein the ultrasound probe is connected to the controlsystem via a cable, wherein the skin surface comprises a wrinkle. 14.The system of claim 12, further comprising an acoustic coupler betweenthe ultrasound probe and the skin surface, wherein the therapy elementis a single element that delivers ultrasound energy at a frequency ofbetween 2 MHz to 25 MHz, wherein the housing further comprises atemperature monitoring sensor.
 15. The system of claim 12, wherein theultrasound therapy element is configured to increase the temperature ofthe tissue in a region of interest to greater than 60° C.
 16. The systemof claim 12, further comprising an ultrasound imaging element co-housedwith the ultrasound therapy element in the probe.
 17. The system ofclaim 12, further comprising a monitoring system, wherein the monitoringsystem is configured to monitor a treatment parameter, wherein thetreatment parameter measured comprises a temperature of the tissue belowthe skin surface.
 18. The system of claim 12, further comprising amotion mechanism for movement of the ultrasound therapy element to forma plurality of thermal lesions at the depth in the region of interest.19. The system of claim 12, further comprising a motion mechanismconfigured for any one of the group consisting of linear, rotational,and variable movement of the ultrasound therapy element.
 20. The systemof claim 12, further comprising a motion mechanism with an encoder formonitoring a position of the ultrasound therapy element, wherein thetherapy element is a single element that delivers the ultrasound therapyenergy at a frequency of between 2 MHz to 25 MHz, wherein the ultrasoundtherapy element is configured to deliver the ultrasound therapy energyat the depth below the skin surface.